CARACTERÍSTICAS.
2.4. Los valores y la educación
2.4.3. Los valores y las prácticas pedagógicas
1) Immunoenzymometric assay was used to assess TFT parameters (FT3, FT4 and TSH). This study was not able to use equilibrium dialysis which is considered the gold standard especially for FT4. Equilibrim Dialysis is expensive and not readily available.
2) HIV RNA viral loads of HIV positive subjects were not done because of cost.
3) Other biochemical assays – TSAabs, TBG, rT3 were not done which could help exclude other thyroid abnormalities.
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127 APPENDIX I
CERTIFICATE OF ETHICAL APPROVAL
128 APPENDIX II CONSENT FORM
I ____________________________________ have heard the details of the study titled “A Study Of Thyroid Function Abnormalities Among Patients With HIV/AIDS In Sagamu, Southwestern, Nigeria” explained to me by Dr. Idowu Akolade O., the coordinator of this research. I have had the opportunity to read through the form, ask questions which have been answered to my satisfaction.
I understand the purpose of this study which is being carried out at the Institute of Human Virology of Nigeria, Olabisi Onabanjo University Teaching Hospital, Sagamu. The risks and benefits of the study have also been explained and I reserve the right to withdraw from the study without any adverse effect on me. I am assured that my identity is protected.
I hereby give my consent to participate fully in the study including clinical examination and necessary studies on my blood sample.
Name of Participant ________________ Signature& Date _____________________
Name of Witness __________________ Signature& Date _____________________
I confirm that I have given an explanation on the purposes, benefits, nature and hazards of this study to the above named participant who has agreed to participate.
Name of Researcher _________________________________
Signature & Date ____________________________________
129 APPENDIX III PROFORMA
A STUDY OF THYROID FUNCTION ABNORMALITIES AMONG PATIENTS WITH HIV/AIDS IN SAGAMU, SOUTHWESTERN, NIGERIA
Study Number _____________ Patient’s Telephone Number ___________________
Hospital Number __________________ Recruitment Date _______________________
SOCIO-DEMOGRAPHIC DATA
Name (Initials only): ______________________________________
Age (Last Birthday): _______________________________________
Tribe: ______________________________
Gender: Male Female m
Occupation: __________________________
Marital Status: ___________ Single/ Married/ Separated/ Divorced/ Widow/ Widower Educational Status: _______________ None/ Primary/Secondary/ Tertiary/ Technical/
Vocational Training/University RESIDENCE: ________________________________
SOCIAL HISTORY
(a) Smoking: Yes/ No, Sticks/day ________________________
Duration (Years) _________________ Pack Years _____________________
(b) Alcohol intake: Yes/No, Regularly/ Occasionally Volume (Quantify) ____________
DATE OF HIV DIAGNOSIS: (Duration of Disease) ___________________________
130 MEDICAL HISTORY
1. Hypertension YES [ ] NO [ ] If Yes, for how long _______________________
2. Diabetes Mellitus YES [ ] NO [ ] If Yes, for how long ________________________
3. Others Specify ________________________________________
DRUG HISTORY
1. HAART YES [ ] NO [ ] Duration of HAART treatment _________________________
If Yes, Specify agents ____________________________
2. Septrin YES [ ] NO [ ] 3. Thyroid Medications YES [ ] NO [ ] 4. Cold Remedies YES [ ] NO [ ] 5. Birth Control Pills YES [ ] NO [ ] 6. Multivitamins YES [ ] NO [ ] 7. Antihypertensives YES [ ] NO [ ]
If Yes, date of commencement ___________________________
8. Antidiabetics YES [ ] NO [ ] 9. Lithium
10. Amiodarone __________________________________
11. Steroid _______________________________________
12. Heparin ___________________________
13. Salicylate_______________________
131
14. Others (Specify) ______________________________________
HISTORY ON THYROID DYSFUNCTION 1. Neck Swelling
(a) Have you ever noticed any swelling in your neck? YES [ ] NO [ ] If Yes, when was it first noticed ___________________________
(b) Do you have any relation with neck swelling YES [ ] NO [ ] If yes, specify:
Parents __________________ Siblings __________________
1st degree Relative ______________ 2nd degree Relative ___________________
Others ________________________
(c) Any difficulty with swallowing YES [ ] NO [ ] 2. Local Symptoms
(a) Any pain in your neck YES [ ] NO [ ]
(b) Dysphasia YES [ ] NO [ ]
HYPOTHYROID FEATURES 1. Hair Changes
Any change in your hair? YES [ ] NO [ ] If Yes:
Falling off? _______________ Thinning Out? _____________________
Fine and Wispy? __________ Loss of Eyebrow and Eyelashes _________________
2. Skin and nail changes
Any change in your skin and hair? YES [ ] NO [ ] Brittle and weak nails? ______________ Break easily? ___________________________
132
Dry and coarse skin?__________ Scaly?________________ Itchy? ____________________
3. Voice changes
Any change in your voice? YES [ ] NO [ ]
Hoarseness? ________ Dry? _____________ Croaky? _____________________
4. Motor/ Sensory changes
Are your muscles weaker than usual YES [ ] NO [ ]
Muscular aches and pains? YES [ ] NO [ ]
Eyes feel gritty, dry and light sensitive? YES [ ] NO [ ]
Do you have less energy than you would like? YES [ ] NO [ ] 5. Psychological changes
Do you experience depression, low moods or lack of motivation? YES [ ] NO [ ]
Low libido/ sex drive? YES [ ] NO [ ]
Do you experience difficulty in concentrating or remembering things? YES [ ] NO [ ] 6. Gastrointestinal changes
Do you suffer from constipation or easy fullness YES [ ] NO [ ] Others
Do you feel cold or commonly have cold hands/feet? YES [ ] NO [ ]
Do you have low tolerance to cold? YES [ ] NO [ ]
Do you notice you gain weight so easily? YES [ ] NO [ ] HYPERTHYROID FEATURES
1. Gastrointestinal Changes
Has your appetite increased? YES [ ] NO [ ]
Do you have problems with Diarrhoea YES [ ] NO [ ]
133 2. Psychological/ Neurological Changes
Anxiety/ Nervousness/ Agitation? YES [ ] NO [ ]
Tremors YES [ ] NO [ ]
3. Others
Do you perspire more than usual? YES [ ] NO [ ]
Heat tolerance? YES [ ] NO [ ]
Is your menstrual cycle normal? YES [ ] NO [ ]
Have you lost weight in the past six months? YES [ ] NO [ ] 4. Eye Changes
Lid lag YES [ ] NO [ ]
Lid retraction YES [ ] NO [ ]
Exophthalmos YES [ ] NO [ ] 5. CVS Changes
Palpitations YES [ ] NO [ ] ANTHROPOMETRIC INDICES
General Examination:
Height (m) _____ Waist circumference ______ Weight (kg) ________ BMI (kg/m2) ________
Cardiovascular Exam
Pulse _______________________ b/m Blood Pressure _______________ mmHg Rhythm: Regular _____________________ Irregular ____________________
134 Thyroid Examination
[Tick as appropriate]
Grade 1 Palpable goitre [ ]
1A Thyroid gland detectable only on palpation [ ]
1B Thyroid gland palpable and visible with neck extended [ ] Grade 2 Goitre visible with neck is normal position [ ]
Grade 3 Large Goitre visible from a distance. [ ]
Laboratory Parameters
1. Current CD4 Count (Cells/mm3) __________
2. Thyroid Function Test
TSH __________(µIU/ml) F T4 ____________(ng/dl) FT3 ______________(pg/ml) Thyroid Autoantibodies
Anti-TPO ____________(AU/ml) Anti-TG _________________(AU/ml) 3. Fasting Lipid Profile
TC___________________________________(mg/dl) LDL-C____________________________________(mg/dl) HDL-C______________________________________(mg/dl) TG_____________________________________(mg/dl)
135 APPENDIX IV
GANTT CHART
Month 1
Month 2
Month 3
Month 4
Month 5
Month 6
Month 7
Month 8 Month 9 Pilot
Study
Sample Collection and thyroid uss Collation of Data
Analysis of
Results&
Write up
136 APPENDIX V FREE T4 ASSAY (TEST PROCEDURE)
All reagents, serum references and controls were brought to room temperature (20-27OC) before proceeding with the assay.
1. The microplate Eliza kit wells was formatted and will be assayed in duplicate.
2. 0.050ml (50µl) of the appropriate serum reference, control serum and test sample was pipetted into the assigned wells.
3. 0.100ml (100µl) of FT4 enzyme reagent was then added to all wells
4. The microplate was swirled gently for 20-30 seconds to mix and allow for adequate reaction.
5. The mixture was incubated for 60minutes at room temperature.
6. The contents of the microplate was discarded by the decantation or aspiration, while decanting contents, the plate was blotted and dried with absorbent paper.
7. Next, 0.300ml (300µl) of washing solution was added to wash the wells adequately. This was repeated two additional times for a total of 3 washes.
8. Then, 0.100ml (100µl) of TMB substrate (Tetramethylbenzidine) will be added to each well at timed intervals and further incubated for 15minutes at room temperature. Next, 0.050ml (50µl) of stop solution was added to each well and gently mixed for 15-20 seconds.
9. Absorbance in each well was then read at 450nm with a microplate reader.
10. Results were read within 30 minutes of adding the stop solution.
APPENDIX VI
137 FREE-T3 ASSAY (TEST PROCEDURE)
1. The desired numbers of coated well were secured in the holder. Data sheet will be made with sample identification.
2. 50µl of samples, controls were dispensed into appropriate wells.
3. Mixture was thoroughly swirled for 10 seconds and 100µl of enzyme conjugate was dispensed into each well
4. This was thoroughly mixed for 30 seconds.
5. The mixture was incubated at room temperature for 60minutes.
6. The microtiter wells were rinsed 5 times with washing buffer.
7. The wells were struck sharply onto absorbent paper to remove residual water droplets then, 100µl of TMB substrate was dispensed into each well and this was gently mixed for 5seconds, and resulted in development of a blue color.
8. The mixture was incubated at room temperature in the dark for 20minutes without shaking.
9. The reactions were stopped by adding 100µl of stop solution (1NH2S04) into each well.
10. The absorbance in each well was read at 450mm with microtitre reader within 15minutes.
APPENDIX VII